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| Name | Class |
|---|---|
| EA Therapeutic Health | UNKNOWN |
| Mayo Clinic | OTHER |
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The goal of this interventional clinical trail is to determine the efficacy of the use of the Neubie pulsed direct current electrical stimulation device for the treatment of participants experiencing mechanical low back pain. The main question it aims to answer is:
Does treatment with the Neubie improve symptoms and time to resolution of back pain compared to standard of care?
Researchers will compare a 12 session treatment physical therapy regimen using the Neubie to standard of care to see if there is a difference in symptom severity and time to resolution.
Participants will:
To determine the efficacy of direct current (DC) electrical stimulation (the Neubie device) on back pain, patients presenting with mechanical, non-radicular low back pain will enroll in a 4 to 6 week treatment regimen at EA Therapeutic Health. The first session will consist of an intake evaluation session that will include: Modified Oswestry Pain Scale, The Schober test for mobility, Heart Rate Variability, and Quality of Life Index. These tests will serve as baseline (and a within subject control) for the intervention.
Participants will then undergo a treatment protocol that incorporates either traditional physical therapy (PT) exercises (standard of care control) or PT exercises with the Neubie utilized concurrently (experimental group). Subjects will undergo an evaluation session prior to starting treatment that includes the Modified Oswestry Pain Scale, The Schober test for mobility, Heart Rate Variability, and Quality of Life Index.
The experimental group subjects will undergo 12 sessions of physical therapy over a 4 to 6-week period which include 45 min of various physical therapy exercises concurrently with the Neubie followed by a 15 minute passive Vagus nerve stimulation protocol with the Neubie.
Control group subjects will participate in a physical therapy protocol that includes manual therapy (e.g. trigger point release, mobilization of the sacroiliac (SI) joint and exercises for back strengthening and stretching. Experimental group subjects will participate in a physical therapy protocol that includes manual therapy (e.g. trigger point release, mobilization of the SI joint) and exercises for back strengthening and stretching in conjunction with Neubie DC e-stim. Both control and experimental groups will receive a customized Home Exercise Program with exercises to be performed at home 1 time a day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Physical Therapy with adjunctive Neubie Pulsed Direct Current Device at 500 pps |
|
| Control | No Intervention | Standard of Care Physical Therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neubie Direct Current Stimulation Device | Device | Pulsed Direct Current Electrical Stimulation Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Oswestry Disability Index | MODIFIED OSWESTRY DISABILITY SCALE - Each question is scored from 0-5 (minimum to maximum). The point total from each section is summed and the then divided by the total number of questions answered and multiplied by 100 to create a percentage disability. The scores range from 0-100% with lower scores meaning less disability. | Pre-intervention |
| Modified Oswestry Disability Index | MODIFIED OSWESTRY DISABILITY SCALE - Each question is scored from 0-5 (minimum to maximum). The point total from each section is summed and the then divided by the total number of questions answered and multiplied by 100 to create a percentage disability. The scores range from 0-100% with lower scores meaning less disability. | 6 weeks |
| Visual Analog Pain Scale | The Visual Analog Scale (VAS) for measuring pain ranges from 0-10, with 0 representing "no pain" and 10 representing "worst pain imaginable". | Pre-intervention |
| Visual Analog Pain Scale | The Visual Analog Scale (VAS) for measuring pain ranges from 0-10, with 0 representing "no pain" and 10 representing "worst pain imaginable". | 6 weeks |
| Schober Test | Schober Test for Spinal Mobility | Pre-intervention |
| Schober Test | Schober Test for Spinal Mobility | 6 weeks |
| Quality of Life Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramona von Leden | Contact | 5303832292 | ramona.vonleden@neu.fit | |
| Melanie Brennan | Contact | melanie@chooseea.org |
| Name | Affiliation | Role |
|---|---|---|
| Ramona von Leden, PhD | NeuFit - Neurological Fitness and Education | Study Director |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2025 | May 13, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Quality of Life Index Score has a range from 0 to 100. Lower values represent poorer quality of life, while higher values indicate better quality of life. |
| Pre-intervention |
| Quality of Life Index | Quality of Life Index Score has a range from 0 to 100. Lower values represent poorer quality of life, while higher values indicate better quality of life. | 6 weeks |
| Heart Math HRV | The Heart Math HRV system takes a reading of the participant's HRV. This is provided in a numerical value which will be used as the HRV "score". | Pre-intervention |
| Heart Math HRV | The Heart Math HRV system takes a reading of the participant's HRV. This is provided in a numerical value which will be used as the HRV "score". | 6 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |